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Vfend (voriconazole) – Labelling - J02AC03

Updated on site: 10-Oct-2017

Medication nameVfend
ATC CodeJ02AC03
Substancevoriconazole
ManufacturerPfizer Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Blister pack for 50 mg film-coated tablets – Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100

1. NAME OF THE MEDICINAL PRODUCT

VFEND 50 mg film-coated tablets

Voriconazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 50 mg voriconazole.

3. LIST OF EXCIPIENTS

Contains lactose monohydrate. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

2 film-coated tablets

10 film-coated tablets

14 film-coated tablets

20 film-coated tablets

28 film-coated tablets

30 film-coated tablets

50 film-coated tablets

56 film-coated tablets

100 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

Sealed Pack

Do not use if box has been opened.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Pfizer Limited

Sandwich

Kent, CT13 9NJ, United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/I/02/212/001 2 film-coated tablets

EU/I/02/212/002 10 film-coated tablets

EU/I/02/212/003 14 film-coated tablets

EU/I/02/212/004 20 film-coated tablets

EU/I/02/212/005 28 film-coated tablets

EU/I/02/212/006 30 film-coated tablets

EU/I/02/212/007 50 film-coated tablets

EU/I/02/212/008 56 film-coated tablets

EU/I/02/212/009 100 film-coated tablets

13. BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

VFEND 50 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister foil for 50 mg film-coated tablets (all blister packs)

1. NAME OF THE MEDICINAL PRODUCT

VFEND 50 mg film-coated tablets

Voriconazole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Pfizer Ltd (as MA Holder logo)

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

Bottle outer pack and bottle label for 50 mg film-coated tablets – Pack of 2, 30, 100

1. NAME OF THE MEDICINAL PRODUCT

VFEND 50 mg film-coated tablets

Voriconazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 50 mg voriconazole.

3. LIST OF EXCIPIENTS

Contains lactose monohydrate. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

2 film-coated tablets

30 film-coated tablets

100 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP:

9. SPECIAL STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Pfizer Limited

Sandwich

Kent, CT13 9NJ, United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/I/02/212/010 2 film-coated tablets

EU/I/02/212/011 30 film-coated tablets

EU/I/02/212/012 100 film-coated tablets

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

VFEND 50 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Blister pack for 200 mg film-coated tablets – Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100

1. NAME OF THE MEDICINAL PRODUCT

VFEND 200 mg film-coated tablets Voriconazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 200 mg voriconazole.

3. LIST OF EXCIPIENTS

Contains lactose monohydrate. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

2 film-coated tablets

10 film-coated tablets

14 fim-coated tablets

20 film-coated tablets

28 film-coated tablets

30 film-coated tablets

50 film-coated tablets

56 film-coated tablets

100 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read enclosed leaflet before use.

Oral use

Sealed Pack

Do not use if box has been opened.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Pfizer Limited

Sandwich

Kent, CT13 9NJ, United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/I/02/212/013 2 film-coated tablets

EU/I/02/212/014 10 film-coated tablets

EU/I/02/212/015 14 film-coated tablets

EU/I/02/212/016 20 film-coated tablets

EU/I/02/212/017 28 film-coated tablets

EU/I/02/212/018 30 film-coated tablets

EU/I/02/212/019 50 film-coated tablets

EU/I/02/212/020 56 film-coated tablets

EU/I/02/212/021 100 film-coated tablets

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

VFEND 200 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister foil for 200 mg film-coated tablets (all blister packs)

1. NAME OF THE MEDICINAL PRODUCT

VFEND 200 mg film-coated tablets

Voriconazole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Pfizer Ltd (as MA Holder logo)

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

Bottle outer pack and bottle label for 200 mg film-coated tablets – Pack of 2, 30, 100

1. NAME OF THE MEDICINAL PRODUCT

VFEND 200 mg film-coated tablets

Voriconazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 200 mg voriconazole.

3. LIST OF EXCIPIENTS

Contains lactose monohydrate. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

2 tablets

30 film-coated tablets

100 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read enclosed leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Pfizer Limited

Sandwich

Kent, CT13 9NJ, United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/I/02/212/022 2 film-coated tablets

EU/I/02/212/023 30 film-coated tablets

EU/I/02/212/024 100 film-coated tablets

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

VFEND 200 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton

1. NAME OF THE MEDICINAL PRODUCT

VFEND 200 mg powder for solution for infusion

Voriconazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 200 mg of voriconazole.

After reconstitution each ml contains 10 mg of voriconazole.

3. LIST OF EXCIPIENTS

Excipient: sulfobutylether beta cyclodextrin sodium. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for solution for infusion 1 vial

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Reconstitute and dilute before use.

Intravenous use only

Not for bolus injection

Single use vial

Infuse at a maximum rate of 3 mg/kg per hour.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

Shelf life after reconstitution: 24 hours when stored at 2°C - 8°C.

9. SPECIAL STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Pfizer Limited

Sandwich

Kent, CT13 9NJ, United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/I/02/212/025

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton

1. NAME OF THE MEDICINAL PRODUCT

VFEND 200 mg powder and solvent for solution for infusion

Voriconazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Vial contains 200 mg of voriconazole.

After reconstitution each ml contains 10 mg of voriconazole.

3. LIST OF EXCIPIENTS

50 ml infusion bag containing 0.9% of sodium chloride.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for infusion Each pack contains:

1 vial of VFEND powder for solution for infusion (single use vial) 1 overwrap

1 vial adaptor

1 syringe

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Please refer to Patient Information Leaflet for detailed instructions.

Reconstitute and dilute before use.

For intravenous use

Not for bolus injection

Not for use with other products

Infuse at a maximum rate of 3 mg/kg per hour.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

Shelf life after reconstitution: 24 hours when stored at 2°C - 8°C.

9. SPECIAL STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Pfizer Limited

Sandwich

Kent, CT13 9NJ, United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/212/027

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

Instructions for Use – please be guided by the pictograms to understand how to use this product.

16. INFORMATION IN BRAILLE

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Label on the vial

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

VFEND 200 mg powder for solution for infusion

Voriconazole

Intravenous use

2. METHOD OF ADMINISTRATION

Reconstitute and dilute before use – see leaflet.

Infuse at a maximum rate of 3 mg/kg per hour.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

200 mg (10 mg/ml)

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Label on the overwrap

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Solvent for VFEND powder for solution for infusion

Sodium Chloride 0.9% in Water for Injections

Intravenous use

2. METHOD OF ADMINISTRATION

Not for bolus injection

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

50 ml

6. OTHER

Keep out of the sight and reach of children.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton

1. NAME OF THE MEDICINAL PRODUCT

VFEND 40 mg/ml powder for oral suspension

Voriconazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml of the constituted suspension contains 40 mg voriconazole.

3. LIST OF EXCIPIENTS

Also contains sucrose. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for oral suspension 1 bottle of 45 g

A measuring cup (graduated to indicate 23 ml), 5 ml oral syringe and a press-in bottle adaptor

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For oral use after constitution

Shake bottle for approximately 10 seconds before use.

Use the oral syringe provided in the pack to measure the correct dose.

Constitution instructions:

Tap the bottle to release the powder.

Add 46 ml of water and shake vigorously for about 1 minute.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

Any remaining suspension should be discarded 14 days after constitution.

9. SPECIAL STORAGE CONDITIONS

Powder: store at in a refrigerator before constitution.

For the constituted oral suspension:

Do not store above 30°C.

Do not refrigerate or freeze.

Keep the container tightly closed.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Pfizer Limited

Sandwich

Kent, CT13 9NJ, United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/212/026

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

VFEND 40 mg/ml

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

Bottle

1. NAME OF THE MEDICINAL PRODUCT

VFEND 40 mg/ml powder for oral suspension

Voriconazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml of the constituted suspension contains 40 mg voriconazole.

3. LIST OF EXCIPIENTS

Also contains sucrose. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for oral suspension 45 g

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leafet before use.

For oral use after constitution

Shake bottle for approximately 10 seconds before use.

Use the oral syringe provided in the pack to measure the correct dose.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

Any remaining suspension should be discarded 14 days after constitution.

Expiry date of the constituted suspension:

9. SPECIAL STORAGE CONDITIONS

Powder: store at in a refrigerator before constitution.

For the constituted oral suspension:

Do not store above 30°C.

Do not refrigerate or freeze.

Keep the container tighly closed.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Pfizer Limited

Sandwich

Kent, CT13 9NJ, United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/I/02/212/026

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

[Justification for not including Braille accepted.]

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